Valsartan 40 mg Tablet, 30-count
Other active recalls for Valsartan (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Angiotensin 2 Receptor Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Valsartan is mainly used to treat high blood pressure, which helps lower your risk of stroke and heart attack. It's also used in adults with heart failure to reduce the chance of b...
- Yes — valsartan tablets can be taken with or without food, so whatever works best for your routine is fine. If you're taking the oral solution, take it as directed by your prescrib...
- Can I take valsartan with or without food?
- Most people do well on valsartan. The most common issues are headache, dizziness, and fatigue. If you feel faint or lightheaded — especially when standing up — that can be a sign y...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Valsartan — tap one for details:
Valsartan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.097 | $2.92 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2834 | $8.50 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.2655 | $7.97 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Valsartan 40 mg 00378-5807-93 | Mylan | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 33342-0062-07 | Macleods | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mgthis 43547-0367-03 | Solco | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 50268-0746-15 | AvPAK | 1 tablet | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 60687-0612-21 | American | 1 tablet | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 65162-0837-03 | Amneal | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 72578-0131-06 | Viona | 30 tablets | $0.097 | AB | Availability likely | — |
| Valsartan 40 mg 72819-0181-03 | Archis | 30 tablets | $0.097 | AB | Discontinued | — |
| Diovan 40 mg 00078-0423-15 | Novartis | 30 tablets | $7.816 | AB | Availability likely | +7934% |
| Valsartan 40 mg 29300-0232-10 | Unichem | 1000 tablets | — | — | FDA listed | — |
| Valsartan 40 mg 31722-0151-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 31722-0745-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 42291-0856-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 42385-0989-05 | Laurus | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 46708-0044-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 50228-0135-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 51660-0140-03 | Ohm | 10 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 53746-0837-05 | Amneal | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 55111-0731-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| valsartan 40 mg 59746-0360-58 | Jubilant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 62332-0044-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 65862-0570-10 | Aurobindo | 10 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 67877-0415-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 70771-1882-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-1337-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-2151-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 71335-2308-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 72789-0553-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 76483-0026-00 | SQUARE | 30 tablets | — | AB | FDA listed | — |
| Valsartan 40 mg 68180-0276-01 | Lupin | 100 tablets | — | — | Discontinued | — |
| Valsartan 40 mg 53401-0033-81 | Aphena | 1080 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 43547-0367-03 You're viewing this | 30 TABLET in 1 BOTTLE (43547-367-03) | $0.0973 / ea | $2.92 | 2015-08-31 | Active |
| 43547-0367-09 | 90 TABLET in 1 BOTTLE (43547-367-09) | $0.0973 / ea | $8.76 | 2015-08-31 | Active |
| 43547-0367-11 | 1000 TABLET in 1 BOTTLE (43547-367-11) | — | — | 2015-08-31 | Active |
| 43547-0367-50 | 500 TABLET in 1 BOTTLE (43547-367-50) | — | — | 2015-08-31 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0973 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 43547-0367-03?
What is the difference between NDC 43547-0367-03 and NDC 43547-0367-09?
What NDC number is used to bill for this package of Valsartan 40 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue valsartan as soon as possible. ( 5.1 ) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue valsartan as soon as possible.
( 5.1 ) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) • Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) • Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 )
1.1Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs.
There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Valsartan tablets may be used alone or in combination with other antihypertensive agents.
1.2Heart Failure Valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (NYHA class II-IV). There is no evidence that valsartan tablets provide added benefits when it is used with an adequate dose of an angiotensin converting enzyme (ACE) inhibitor [ see Clinical Studies (14.2) ].
1.3Post-Myocardial Infarction In clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [ see Clinical Studie…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range * Hypertension Adult ( 2.2 ) 80-160 mg once daily 80-320 mg once daily 1-16 years ( 2.3 ) 1 mg/kg once daily Up to 40 mg daily 1-4 mg/kg once daily Up to 160 mg daily Heart Failure ( 2.4 ) 40 mg twice daily 40-160 mg twice daily Post-Myocardial Infarction ( 2.5 ) 20 mg twice daily 20-160 mg twice daily * As tolerated by patient
2.1Important Dosage and Preparation Information Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets [see Clinical Pharmacology (12.3) ] .
Use of the oral suspension is recommended: • in pediatric patients aged 1 to 5 years • in patients >5 years of age who cannot swallow tablets and • in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of valsartan. When switching between suspension and tablets, the dose of valsartan may need to be adjusted. Preparation of Suspension (for 160 mL of a 4 mg/mL suspension) • Add 80 mL of Ora-Plus ® * oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets and shake for a minimum of 2 minutes. • Allow the suspension to stand for a minimum of 1 hour. • After the standing time, shake the suspension for a minimum of 1 additional minute. • Add 80 mL of Ora-Sweet SF ® * oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. • The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2°C to 8°C/35°F to 46°F) in the glass bottle with a child-resistant screw-cap closure. • Shake the bottle well (at least 10 seconds) prior to dispensing the suspension. *Ora-Sweet SF ® and Ora-Plus ® are registered trademarks of Paddock Laboratories, Inc.
2.2Adult Hypertension The recommended starting dose of valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.
Valsartan may be administered with other antihypertensive agents.
2.3Pediatric Hypertension 1 to 16 Years of Age The usual recommended starting dose is 1 mg/kg once daily (up to 40 mg total). A higher starting dose of 2 mg/kg may be considered in selected cases when a greater reduction of blood pressure is needed. The dosage should be adjusted according to blood pressure response and tolerability, up to a maximum dose of 4 mg/kg once daily (maximum daily dose 160 mg).
No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate < 30 mL/min/1.73 m 2 [see Use in Specific Populations (8.4) ]. Use of valsartan tablets is not recommended in children less than 1 year of age [ see Adverse Reactions (6.1) , Pediatric Use in Specific Populations (8.4) , Nonclinical Toxicology (13.2) ].
2.4Heart Failure The recommended starting dose of valsartan is 40 mg twice daily. Uptitrate to 80 mg and 160 mg twice daily or to the highest dose tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.
2.5Post-Myocardial Infarction Valsartan may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of vals…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 40 mg are scored yellow, capsule-shaped, biconvex, film-coated tablets debossed with “341” and bisect between 3 and 41 on one side, and “HH” on the other side. 80 mg are brown, capsule-shaped, biconvex, film-coated tablets debossed with “342” on one side and “HH” on the other side. 160 mg are yellow, capsule-shaped, biconvex, film-coated tablets debossed with “343” on one side and “HH” on the other side.
320 mg are brown, capsule-shaped, biconvex, film-coated tablets debossed with “344” on one side and “HH” on the other side. Tablets (mg): 40 (scored), 80, 160, 320 (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes [ see Drug Interactions (7.3) ]. Known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Observe for signs and symptoms of hypotension ( 5.2 ) • Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 )
5.1Fetal Toxicity Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan as soon as possible [ see Use in Specific Populations (8.1) ].
5.2Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision.
Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the VALsartan In Acute myocardial iNfarcTion trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients.
If excessive hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients.
Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan [ see Drug Interactions (7) ].
5.4Hyperkalemia Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required [ see Adverse Reactions (6.1) ] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall incidence of adverse reactions with valsartan was similar to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, race, or regimen. Discontinuation of therapy due to side effects was required in 2.3% of valsartan patients and 2.0% of placebo patients.
The most common reasons for discontinuation of therapy with valsartan were headache and dizziness. The adverse reactions that occurred in placebo-controlled clinical trials in at least 1% of patients treated with valsartan and at a higher incidence in valsartan (n=2,316) than placebo (n=888) patients included viral infection (3% vs. 2%), fatigue (2% vs.
1%), and abdominal pain (2% vs. 1%). In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE-inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%).
In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001). Dose-related orthostatic effects were seen in less than 1% of patients. An increase in the incidence of dizziness was observed in patients treated with valsartan 320 mg (8%) compared to 10 to 160 mg (2% to 4%).
Pediatric Hypertension Valsartan has been evaluated for safety in 290 pediatric patients aged 1 to less than 6 years and over 400 patients aged 6 to 17 years. No relevant differences were identified between the adverse experience profile for pediatric patients and that previously reported for adult patients. Hyperkalemia was more frequently observed in pediatric patients aged 1 to 17 years with underlying chronic kidney disease (CKD).
Cases of elevated ALT and/or AST have been reported in pediatric patients 1 to less than 6 years of age. These events occurred in a study population which frequently had significant comorbidities; hence, a causal relationship to valsartan could not be established. Heart Failure In the Valsartan Heart Failure Trial (Val-HeFT), comparing valsartan in total daily doses up to 320 mg (n=2,506) to placebo (n=2,494), 10% of valsartan patients discontinued for adverse reactions vs.
7% of placebo patients. The table shows adverse reactions in double-blind short-term heart failure trials, including the first 4 months of the Valsartan Heart Failure Trial, with an incidence of at least 2% that were more frequent in valsartan-treated patients than in placebo-treated patients. All patients received standard drug therapy for heart failure, frequently as multiple medications, which could include diuretics, digitalis, beta-blockers.
About 93% of patients received concomitant…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine ( 7.1 ) • Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2) • Dual inhibition of the Renin-Angiotensin System (RAS): Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ) • Lithium: Increases in serum lithium level and lithium toxicity ( 7.4 )
7.1Agents Increasing Serum Potassium Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.
7.2Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.
7.3Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy [ see Clinical Studies (14.3 )] . In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR < 60 mL/min).
7.4Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8. 2) Pediatrics : Use of valsartan tablets is not recommended in children less than 1 year of age ( 6.1 , 8.4 , 13.2 )
8.1Pregnancy Risk Summary Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.
Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan ( see Clinical Considerations ). When pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking valsartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data No teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (MRHD) on a mg/m 2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day.
In rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. In rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed.
8.2Lactation Risk Summary There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Because of the potential for s…
🆘 Overdosage ▾
10 OVERDOSAGE Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported.
If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2,000 mg/kg in rats and up to 1,000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD dose on a mg/m 2 basis) (Calculations assume an oral dose of 320 mg/day and a 60-kg patient).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.
Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT 1 receptor than for the AT 2 receptor.
The increased plasma levels of angiotensin II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT 1 receptor about one-200 th (1/200 th ) that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension.
ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known.
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
12.2Pharmacodynamics Valsartan inhibits the pressor effect of angiotensin II infusions. An oral dose of 80 mg inhibits the pressor effect by about 80% at peak with approximately 30% inhibition persisting for 24 hours. No information on the effect of larger doses is available.
Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan; very little effect on serum potassium was observed. In multiple-dose studies in hypertensive patients with stable renal insufficiency and patients with renovascular hypertension, valsartan had no clinically significant effects on glomerular filtration rate, filtration fraction, creatinine clearance, or renal plasma flow.
In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid.
12.3Pharmacokinetics Absorption In healthy volunteers, valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. Absolute bioavailability for valsartan is about 25% (range 10% to 35%).
The bioavailability of the suspension [ see Dosage and Administration (2.2) ] is 1.6 times as great as with the tablet. AUC and C max values of valsartan increase approximately linearly with increasing dose over the clinical dosing range (80-320 mg). Valsartan does not accumulate appreciably in plasma following repeated administration of 200 mg once daily.
In heart failure patients, the average time to peak plasma concentration and elimination half-life of valsartan are similar to those observed in healthy volunteers. The average accumulatio…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan tablets, USP, are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. The 40 mg tablets are scored on one side and biconvex and capsule-shaped.
The 80 mg, 160 mg, and 320 mg tablets are unscored and biconvex and capsule-shaped as well. Tablet Color Deboss NDC 43547-###-## Side 1 Side 2 Bottle of 30 90 500 1,000 40 mg Yellow HH 341 367-03 367-09 367-50 367-11 80 mg Brown HH 342 368-03 368-09 368-50 368-11 160 mg Yellow HH 343 369-03 369-09 369-50 369-11 320 mg Brown HH 344 370-03 370-09 370-50 370-11 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect from moisture.
Dispense in tight container (USP).
📋 Description ▾
11 DESCRIPTION Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan, USP is a white to practically white fine powder.
It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.
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💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy : Advise female patients of childbearing age about the consequences of exposure to valsartan during pregnancy. Discuss treatment options with women planning to become pregnant.
Ask patients to report pregnancies to their healthcare provider as soon as possible [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ]. Lactation: Advise women not to breastfeed during treatment with valsartan [see Use in Specific Populations (8.2) ]. Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider.
Tell patients that if syncope occurs to discontinue valsartan until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.2) ]. Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions (7.1) ].
Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Zhejiang Huahai Pharmaceutical Technology Co., Ltd. Jiangnan, Linhai, Zhejiang 317000, China Revised: 08/2025 200281-04 (ZHP Xunqiao) 205940-01 (ZHT Jiangnan)
💬 Medication Guide ▾
PATIENT INFORMATION Valsartan Tablets (val-SAR-tan), USP What is the most important information I should know about valsartan? Valsartan can cause harm or death to an unborn baby. • Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant. • If you become pregnant during treatment with valsartan, stop taking valsartan and tell your healthcare provider right away. What is valsartan?
Valsartan is a prescription medicine used in: • adults and children 1 year of age and older to lower high blood pressure (hypertension). Valsartan may be used alone or in combination with other blood pressure medicines. • adults to treat heart failure. Valsartan may help decrease your need for hospitalization that happens with heart failure. • adults with certain types of heart failure, to increase the chance of living longer after a heart attack (myocardial infarction).
Valsartan should not be used to treat high blood pressure in children less than 1 year of age. It is not known if Valsartan is safe and effective in children with certain kidney problems. Do not take valsartan if you: • are allergic to any of the ingredients in valsartan.
See the end of this leaflet for a complete list of ingredients in valsartan. • have diabetes and are also taking aliskiren. Talk to your healthcare provider if you are not sure. Before taking valsartan, tell your healthcare provider about all of your medical conditions including, if you: • have heart problems • have kidney problems • are pregnant or plan to become pregnant .
See “ What is the most important information I should know about valsartan?” • are breastfeeding or plan to breastfeed. It is not known if valsartan passes into your breast milk. You should not breastfeed during treatment with valsartan.
Talk with your healthcare provider about the best way to feed your baby during your treatment with valsartan. Tell your healthcare provider about all the medicines you take including prescription and over- the-counter medicines, vitamins and herbal supplements. Valsartan may affect the way other medicines work.
Especially tell your healthcare provider if you take: • other medicines for high blood pressure or a heart problem • water pills (also called “diuretics”) • potassium-containing medicines, potassium supplements or salt substitutes containing potassium. Your healthcare provider may check the amount of potassium in your blood regularly. • nonsteroidal anti-inflammatory drugs (NSAIDs) • Lithium. Your healthcare provider will check the amount of lithium in your blood regularly.
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when a new medicine is prescribed. Talk to your healthcare provider or pharmacist before you start taking any new medicine.
How should I take valsartan? • Take valsartan exactly as prescribed by your healthcare provider. • For treatment of high blood pressure, take valsartan 1 time each day • For children: Your pharmacist will mix valsartan as a liquid suspension for your child, if: o your child is 1 to 5 years of age, or o your child is older than 5 years of age and cannot swallow tablets, or o if tablets are not available in the prescribed strength needed for your child • If your child switches between taking the tablet and the suspension, your healthcare provider will adjust the dose as needed. o Shake the bottle of suspension well for at least 10 seconds before pouring the dose of medicine to give to your child. • For adults with heart failure or who have had a heart attack, take valsartan 2 times each day.
Your healthcare provider may start you on a low dose of valsartan and may increase the dose during your treatment. • Valsartan can be taken with or without food. • If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time. dose, do not take the missed dose.
Take…